H. Pylori Antigen Detection Test Kit
For the qualitative detection of Antigens to H. pylori in feces
Main Features
☀ High Sensitivity: 100%
☀ Specificity: 100%
☀ Reliable: Accuracy higher than 97.5%, early detection of the
presence of H.Pylori Antigens
☀ Easy: Room Temperature Storage, Built-In Control Line
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Simple: No Instrument Required
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Summary and Explanation of The Test
The infection of Helicobacter pylori (H. pylori) is associated with
a variety of gastro-intestinal diseases, such as stomach ulcer,
chronic active gastritis and gastric, duodenal and gastric
adenocarcinoma.
Detecting these specific antibodies to H. pylori can be used as a
qualitative assay in the diagnosis of H. pylori infection. It may
be used either as an adjunction to endoscopy or as an alternative
measure in symptomatic patients.
The H. pylori Antigen Detection Test kit is a chromatographic
immunoassay (CIA) for the rapid determination of antigens to H.
pylori in feces specimens. The test is to be used as an aid in the
diagnosis of infection due to H. pylori.
Materials Required But Not Provided
Clock or Timer
Warning and Precautions
☀ For in vitro diagnostic use only.
☀ All patient samples should be treated as if capable of transmitting
diseases.
☀ Do not interchange reagents from different lots or use test kit
beyond expiration date.
☀ Interference substance in the samples or failed operation may cause
false result. Please retest with a new one or use other way to
confirm.
☀ Patient specimens may contain infectious agents and should be
handled as capable of transmitting disease. Wear disposable gloves
throughout the specimen collection and assay procedures.
Sample Collection and Preparation
☀ Collect stool sample by using the sample collection device
provided.
☀ Unscrew the top of the sample collection device, take out the
sample collection stick, and collect the sample by dipping the
stick into 3 different places of the stool sample.
☀ Put the sample collection stick back in the sample collection
device and screw together tightly.
☀ If the sample cannot be tested on the day of collection, store the
stool sample at 4℃ for up to 7 days. Bring the specimen to room
temperature before test.
Assay Procedure
☀ Remove the test device from foil pouch by tearing along the notch.
☀ Specimen collection. Please see Specimen Collection and Preparation.
☀ Shake the sample collection device several times.
☀ Holding the sample collection device upright, carefully screw off
the cap of collection device.
☀ Squeeze 2-3 drops (80-100ul) of the sample solution on the test
cassette.
☀ Observe the result in15 minutes.
Interpretation of Results
Negative: Only one pink band appears. This indicates that no H. pylori
antibodies have been detected.
Positive: Two pink bands appear. This indicates that the specimen contains
H. pylori antibodies.
Invalid: If no band appears, this indicates a possible error in performing
the test. The test should be repeated using a new device.
Storage
The H. pylori Rapid Test should be stored at temperature 4-30°C the
sealed pouch for the duration of the shelf life (24months).
Do the test in 1 hour when you open the pouch
Limitation of The Procedure
1. The test is to be used for the qualitative detection of antigens
to H. pylori.
2. A negative result does not rule out infection by H. pylori
because the antigens to H. pylori may be absent or may not be
present in sufficient quality to be detected at early stage of
infection.
